NCT05649787Completed
Effects of a Supervised Training Program on Functional Capacity in Patients With HFpEF and Chronotropic Incompetence
Effects of a Supervised Training Program on Functional Capacity in Patients With Heart Failure and Preserved Ejection Function and Chronotropic Incompetence
Source: ClinicalTrials.gov · Last updated 27 Feb 2025
Brief summary (registry, in English)
This is a prospective study, blinded for the evaluator, randomized (1:1:1:1) to receive standard management alone or combined with a program of training (aerobic alone or combined with strength exercises) that will be carried out in a single centre. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12 weeks. Patients with heart failure with preserved ejection fraction, functional class NYHA II-III, and chronotropic incompetence criteria will be enrolled. A sample size estimation \[alfa: 0.05, power: 80%, a 15% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)\] of 80 patients (20 per arm) would be necessary to test our hypothesis.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 22 Nov 2022
- Start date
- 18 Jan 2023
- Primary completion date
- 18 Nov 2024
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Diseases
- Heart failure
- NCT number
- NCT05649787
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 18 Jan 2023 to the primary completion date, 18 Nov 2024
- 1 site 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.
Other illness
- Cardiac pacemaker
- Significant primary moderate-to-severe valve disease
- Effort angina or signs of ischemia during CPET
- Cardiac transplantation
Other
- Inability to perform a valid baseline cardiopulmonary exercise test
- Primary cardiomyopathies
- Any other comorbidity with a life expectancy of less than one year
Who the study is looking for
- Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure.
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) \>125 pg/mL in the last month
- Stable symptomatic heart failure patients (New York Heart Association functional class II-III/IV) during the last month
- Age ≥ 60 years old.
- Blunted heart rate (HR) response during a maximal cardiopulmonary exercise testing (CPET), defined as a chronotropic index \<0.62 if previous treatment with Beta-blockers or chronotropic index \<0.80 in patients without beta-blockers. Chronotropic index= \[HRpeak exercise - HRrest\] / \[220 - age - HRrest\]
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| INCLIVA Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.