NCT03453268Completed
Impact of Reducing Antihypertensive Treatment on Mortality in Frail Subjects With Low Systolic Blood Pressure (SBP).
Impact of Reducing Antihypertensive Treatment on Mortality in Frail Subjects With Low Systolic Blood Pressure (SBP). Multicenter, Randomized Controlled Study of Subjects Aged 80 and Over, Living in Nursing Homes and Other IMS.
Source: ClinicalTrials.gov · Last updated 20 Jul 2025
Brief summary (registry, in English)
The investigators hypothesize that a gradual reduction in antihypertensive treatment in medical-social institutions patients with low systolic blood pressure (SBP) can improve survival through a controlled increase in SBP and a decrease in secondary morbidity due to 'overmedication'. Accordingly, the investigators propose a randomized, case/control trial in NH patients ≥ 80 years with a SBP\<130 mmHg with \>1 anti-Htn drugs. This trial will consist of two parallel arms: the intervention arm will entail antihypertensive drug step-down, while the control arm will comprise the standard anti-hypertensive treatment.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1048 (actual)
- First submitted
- 31 Jan 2018
- Start date
- 2 Oct 2018
- Primary completion date
- 15 Aug 2024
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- High blood pressure
- NCT number
- NCT03453268
What you commit to
- Study type: Interventional
- Participants enrolled: 1048
- From 2 Oct 2018 to the primary completion date, 15 Aug 2024
- 124 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Patients in whom no antihypertensive molecule can be reduced for specific reasons (heart failure with ejection fraction \<40%, fluid retention due to heart failure, coronary artery disease and diabetic nephropathy).
Other
- Patients with an estimated life expectancy of \<3 months
- Patients who have already been included in this study or in another study at the same time
Who the study is looking for
- Male and female patients aged 80 and over
- Patients living in nursing homes
- Patients with a SBP \< 130 mmHg measured in Medical-Social Institutions using the connected blood pressure monitor supplied for the study (average of the last 2 out of 3 measurements after 10 min rest)
- Hypertensive patients whose treatment contains at least 2 antihypertensive molecules and whose treatment has been stabilised for at least :
- 3 weeks in the case of the introduction or discontinuation of an anti-HBP drug
- 2 weeks in the case of a change in the dosage of one of the anti-HBP drugs.
- Patients affiliated to a social security scheme
- Patients who have signed the informed consent form (failing which, the legal representative)
- Patients with dementia or with a severe reduction in physical function (impaired vision, asthenia, advanced osteoarthritis, severe tremors, etc.) and/or cognitive function may be included in this study with the agreement of their carers or family/relatives.
Age in the registry: 80 years to - · Sex: All · Does not accept healthy volunteers
Sites (124)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Angoulême (Expert center) Coordinator of this site? Confirm its status | Angoulême | France | Unknown status |
| Font Douce (Nursing Home) Coordinator of this site? Confirm its status | Angoulême | France | Unknown status |
| Kerleano (Nursing Home) Coordinator of this site? Confirm its status | Auray | France | Unknown status |
| Keriolet (Nursing Home) Coordinator of this site? Confirm its status | Auray | France | Unknown status |
| Le Parc de la Plesse (Nursing Home) Coordinator of this site? Confirm its status | Avrillé | France | Unknown status |
| Sentiers d'Automne (Nursing Home) Coordinator of this site? Confirm its status | Bains-les-Bains | France | Unknown status |
| Parisot (Nursing Home) Coordinator of this site? Confirm its status | Bainville-sur-Madon | France | Unknown status |
| EHPAD Fontarce (Nursing Home) Coordinator of this site? Confirm its status | Bar-sur-Seine | France | Unknown status |
| EHPAD du CH (Nursing Home) Coordinator of this site? Confirm its status | Bar-sur-Seine | France | Unknown status |
| USLD du CH (Nursing Home) Coordinator of this site? Confirm its status | Bar-sur-Seine | France | Unknown status |
| Saint Charles (Nursing Home) Coordinator of this site? Confirm its status | Bayon | France | Unknown status |
| Argia (Nursing Home) Coordinator of this site? Confirm its status | Bayonne | France | Unknown status |
| Goxoki (Nursing Home) Coordinator of this site? Confirm its status | Bayonne | France | Unknown status |
| EHPAD du Prisse (Nursing home) Coordinator of this site? Confirm its status | Bayonne | France | Unknown status |
| EHPAD CH de Valence (Nursing home) Coordinator of this site? Confirm its status | Beauvallon | France | Unknown status |
| USLD Espace Perréal (Nursing Home) Coordinator of this site? Confirm its status | Béziers | France | Unknown status |
| Espace Perréal (Nursing Home) Coordinator of this site? Confirm its status | Béziers | France | Unknown status |
| EHPAD Simone de Beauvoir (Nursing Home) Coordinator of this site? Confirm its status | Béziers | France | Unknown status |
| CHU Bordeaux (Expert center) Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| La Croix Du Gue (Nursing Home) Coordinator of this site? Confirm its status | Bouguenais | France | Unknown status |
| Poincaré (Nursing Home) Coordinator of this site? Confirm its status | Bouxières-aux-Dames | France | Unknown status |
| Les Rives d'Ode (Nursing Home) Coordinator of this site? Confirm its status | Carcassonne | France | Unknown status |
| Les jardin de Sophia (Nursing Home) Coordinator of this site? Confirm its status | Castelnau-le-Lez | France | Unknown status |
| EHPAD de Monges (Nursing Home) Coordinator of this site? Confirm its status | Castres | France | Unknown status |
| La Villégiale Saint Jacques (Nursing Home) Coordinator of this site? Confirm its status | Castres | France | Unknown status |
| Saint Martin (Nursing Home) Coordinator of this site? Confirm its status | Charmes | France | Unknown status |
| Saint Jean (Nursing Home) Coordinator of this site? Confirm its status | Charmois-l'Orgueilleux | France | Unknown status |
| EHPAD CH Cotentin Pasteur (Nursing Home) Coordinator of this site? Confirm its status | Cherbourg | France | Unknown status |
| Centre pour Personnes Agées (Nursing Home) Coordinator of this site? Confirm its status | Colmar | France | Unknown status |
| Diaconnat (Nursing home) Coordinator of this site? Confirm its status | Colmar | France | Unknown status |
| Chantereine-Orpea (Nursing Home) Coordinator of this site? Confirm its status | Coubron | France | Unknown status |
| Le Hameau de Saubagnacq (Nursing Home) Coordinator of this site? Confirm its status | Dax | France | Unknown status |
| Les Bégonias (Nursing Home) Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Les marguerites (Nursing Home) Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Port du Canal (Nursing Home) Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| EHPAD CHU Dijon Bourgogne (Nursing Home) Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHU Dijon (Expert center) Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| EHPAD Simone Veil (Nursing Home) Coordinator of this site? Confirm its status | Eaubonne | France | Unknown status |
| Bas-Château (Nursing Home) Coordinator of this site? Confirm its status | Essey-lès-Nancy | France | Unknown status |
| Belfontaine (Nursing Home) Coordinator of this site? Confirm its status | Fontaine-lès-Dijon | France | Unknown status |
| Accueil Vologne (Nursing Home) Coordinator of this site? Confirm its status | Granges-sur-Vologne | France | Unknown status |
| Vallée Don (Nursing Home) Coordinator of this site? Confirm its status | Guémené-Penfao | France | Unknown status |
| EHPAD Orpéa (Nursing home) Coordinator of this site? Confirm its status | La Talaudière | France | Unknown status |
| Baudinet De Courcelles (Nursing home) Coordinator of this site? Confirm its status | Lay-Saint-Christophe | France | Unknown status |
| CHU Lille (Expert center) Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Les Bateliers (Nursing Home) Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Saint Antoine de Padoue (Nursing Home) Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| EHPAD de Lormont (Nursing Home) Coordinator of this site? Confirm its status | Lormont | France | Unknown status |
| Sainte Thérèse (Nursing Home) Coordinator of this site? Confirm its status | Ludres | France | Unknown status |
| Saint Charles (Nursing Home) Coordinator of this site? Confirm its status | Lunéville | France | Unknown status |
| EHPAD Constant (Nursing Home) Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| CHU Lyon (Expert center) Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| La Renaissance-Orpea (Nursing Home) Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Bon repos (Nursing Home) Coordinator of this site? Confirm its status | Maxéville | France | Unknown status |
| Saint Sauveur (Nursing Home) Coordinator of this site? Confirm its status | Maxéville | France | Unknown status |
| Félix Marechal (Nursing Home) Coordinator of this site? Confirm its status | Metz | France | Unknown status |
| USLD Nouvielle (Nursing Home) Coordinator of this site? Confirm its status | Mont-de-Marsan | France | Unknown status |
| Jeanne Callarec (Nursing Home) Coordinator of this site? Confirm its status | Montmorency | France | Unknown status |
| Coteaux de Montmorency (Nursing Home) Coordinator of this site? Confirm its status | Montmorency | France | Unknown status |
| CHU Montpellier (Expert center) Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Antonin Balmès (Nursing Home) Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CSPA Bellevue (Nursing Home) Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| EHPAD du CH (Nursing Home) Coordinator of this site? Confirm its status | Muret | France | Unknown status |
| Notre Maison (Nursing home) Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| Gériatrie - CHRU de Nancy (Expert center) Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| Les Cygnes (Nursing Home) Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| Saint Charles EHPAD (Nursing Home) Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| Saint Joseph (Nursing Home) Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| Saint Stanislas (Nursing Home) Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| Saint Charles USLD (Nursing Home) Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| La Chézalière LNA Santé (Nursing Home) Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| CHU Nantes (Expert center) Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Beauséjour (Nursing Home) Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| CHU Nice (Expert center) Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| EHPAD Cimiez du CHU (Nursing Home) Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| EHPAD GHAM (Nursing Home) Coordinator of this site? Confirm its status | Nogent-sur-Seine | France | Unknown status |
| Bethel (Nursing Home) Coordinator of this site? Confirm its status | Oberhausbergen | France | Unknown status |
| Les Jardins d'Olonne (Nursing Home) Coordinator of this site? Confirm its status | Olonne-sur-Mer | France | Unknown status |
| Résidence Mer et Estuaire (Nursing Home) Coordinator of this site? Confirm its status | Paimboeuf | France | Unknown status |
| EHPAD Broca (Nursing Home) Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| La Collégiale (Nursing Home) Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Saint Jacques Orpea (Nursing Home) Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| APHP (Expert center) Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Trocadéro-Orpéa (Nursing Home) Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Périgueux (Expert center) Coordinator of this site? Confirm its status | Périgueux | France | Unknown status |
| EHPAD Parrot (Nursing Home) Coordinator of this site? Confirm its status | Périgueux | France | Unknown status |
| USLD Pessac (Nursing Home) Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
| Avant-Garde (Nursing Home) Coordinator of this site? Confirm its status | Pompey | France | Unknown status |
| La Salle (Nursing Home) Coordinator of this site? Confirm its status | Pompey | France | Unknown status |
| Nazareth (Nursing Home) Coordinator of this site? Confirm its status | Pont-Sainte-Marie | France | Unknown status |
| Saint Jean (Nursing Home) Coordinator of this site? Confirm its status | Portieux | France | Unknown status |
| Jacques Mellez (Nursing Home) Coordinator of this site? Confirm its status | Raon-l'Étape | France | Unknown status |
| Résidence Roux CHU Reims (Nursing Home) Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| CHU Reims (Expert center) Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| AHPAD AB2 Wilson (Nursing Home) Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| Le Clos des platanes (Nursing Home) Coordinator of this site? Confirm its status | Romilly-sur-Seine | France | Unknown status |
| Julien Monnard (Nursing Home) Coordinator of this site? Confirm its status | Romilly-sur-Seine | France | Unknown status |
| Mer et Pins Fleur d'Ajonc (Nursing Home) Coordinator of this site? Confirm its status | Saint-Brevin-les-Pins | France | Unknown status |
| EHPAD Mer Et Pins (Nursing Home) Coordinator of this site? Confirm its status | Saint-Brevin-les-Pins | France | Unknown status |
| Mer et Pins les Sylphes (Nursing Home) Coordinator of this site? Confirm its status | Saint-Brevin-les-Pins | France | Unknown status |
| Saint Deodat (Nursing Home) Coordinator of this site? Confirm its status | Saint-Dié | France | Unknown status |
| Fauriel (Nursing Home) Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| EHPAD de Saint Genest (Nursing Home) Coordinator of this site? Confirm its status | Saint-Genest | France | Unknown status |
| Udazkena (Nursing Home) Coordinator of this site? Confirm its status | Saint-Jean-de-Luz | France | Unknown status |
| Hotel Club (Nursing Home) Coordinator of this site? Confirm its status | Saint-Max | France | Unknown status |
| EHPAD De Senones (Nursing Home) Coordinator of this site? Confirm its status | Senones | France | Unknown status |
| EHPAD Sézanne (Nursing Home) Coordinator of this site? Confirm its status | Sézanne | France | Unknown status |
| EHPAD CHRU Robertsau (Nursing Home) Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| EHPAD Bois Fleuri (Nursing Home) Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| CHU Strasbourg (Expert center) Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| La Christinière ACPPA (Nursing Home) Coordinator of this site? Confirm its status | Taluyers | France | Unknown status |
| Sainte Sophie (Nursing Home) Coordinator of this site? Confirm its status | Thiaucourt-Regniéville | France | Unknown status |
| CHU Toulouse (Expert center) Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Jolimont Marengo Orpea (Nursing Home) Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Clinique les Minimes (Nursing Home) Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Klarene-Orpea (Nursing Home) Coordinator of this site? Confirm its status | Tournan-en-Brie | France | Unknown status |
| CHP Cotentin Simone Veil (Nursing Home) Coordinator of this site? Confirm its status | Valognes | France | Unknown status |
| USLD Maison du Lac (Nursing Home) Coordinator of this site? Confirm its status | Vannes | France | Unknown status |
| EHPAD Maison du Lac (Nursing Home) Coordinator of this site? Confirm its status | Vannes | France | Unknown status |
| Sainte Catherine (Nursing Home) Coordinator of this site? Confirm its status | Verdun | France | Unknown status |
| Montagne de Reims (Nursing home) Coordinator of this site? Confirm its status | Villers-Allerand | France | Unknown status |
| Villa Saint-Pierre (Nursing Home) Coordinator of this site? Confirm its status | Villers-lès-Nancy | France | Unknown status |
| Saint Joseph (Nursing Home) Coordinator of this site? Confirm its status | Ville-sur-Illon | France | Unknown status |
| Les Buissons (Nursing Home) Coordinator of this site? Confirm its status | Xertigny | France | Unknown status |
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