NCT07925515Not yet recruiting
High-Intensity Interval Versus Aerobic Training for Patient-Reported Outcomes in Women With Heart Failure.
Entrenamiento interválico de Alta Intensidad Versus Entrenamiento aeróbico Para Resultados Reportados Por Pacientes en Mujeres Con Insuficiencia cardíaca (HIIT-WHEF, High-intensity Interval Versus Aerobic Training for Patient-reported Outcomes in Women With Heart Failure): un Ensayo clínico Piloto, Prospectivo, Aleatorizado y de Factibilidad.
Source: ClinicalTrials.gov · Last updated 9 Nov 2026
Brief summary (registry, in English)
Heart failure is associated with impaired health-related quality of life and reduced exercise capacity. Women remain under-represented in cardiac rehabilitation research, and evidence comparing high-intensity interval training (HIIT) with moderate-intensity continuous training (MICT) in women with heart failure is limited. HIIT-WHEF is a prospective, single-centre, randomised pilot feasibility trial involving 36 women aged 18 years or older with heart failure and a left ventricular ejection fraction below 50%. Participants will be randomly allocated in a 1:1 ratio to a 12-week supervised cardiac rehabilitation programme incorporating either HIIT or MICT. Both groups will also undertake individualised resistance training. The primary objectives are to assess the feasibility and safety of conducting the randomised trial, including recruitment, acceptance, retention, adherence, intervention fidelity, completeness of outcome data and exercise-related adverse events. Health-related quality of life, assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ), is the key clinical outcome of interest. Peak oxygen uptake, left ventricular ejection fraction and biomarkers will be assessed as exploratory clinical outcomes. The study is designed to inform the planning of a future adequately powered confirmatory trial. It is not intended to establish definitive evidence of the superiority of HIIT over MICT.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 3 Nov 2026
- Start date
- Nov 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Universidad Internacional Isabel I de Castilla
- Diseases
- Heart failure
- NCT number
- NCT07925515
What you commit to
- Study type: Interventional
- Planned participants: 36
- From Nov 2026 to the primary completion date, Dec 2027
- 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 design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with heart failure and a weakened heart pumping function. It compares two kinds of supervised exercise training over 12 weeks.
- Age
- 18 years or older.
- Sex
- Women only.
- Disease stage
- Heart failure with a left ventricular ejection fraction below 50%, with stable symptoms in New York Heart Association class I-II.
- Earlier treatment
- Must be on stable heart failure medicine at the highest doses they can tolerate, and referred by their cardiologist for cardiac rehabilitation.
- Biomarker or test result
- Left ventricular ejection fraction below 50%.
Main reasons for not taking part
- Acute coronary syndrome or heart surgery in the previous 15 days
- Uncontrolled irregular heartbeat
- Severe heart valve disease that needs a procedure
- Bone, muscle or nerve problems that prevent exercise
- Unstable or worsening heart failure, or any condition that makes exercise unsafe
Read by machine on 10 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute coronary syndrome or cardiac surgery within the previous 15 days.
Other illness
- Uncontrolled arrhythmias.
- Severe valvular heart disease with an indication for intervention.
- Clinical or haemodynamic instability, decompensated heart failure, unstable angina, clinically significant uncontrolled arrhythmias, or any other cardiovascular or non-cardiovascular condition that, in the judgement of the responsible clinical team, makes exercise unsafe at the time of assessment.
Other
- Musculoskeletal or neurological limitations that prevent the performance of exercise.
- Any contraindication to cardiopulmonary exercise testing or high-intensity exercise training.
Who the study is looking for
- Women aged 18 years or older.
- Documented diagnosis of heart failure with a left ventricular ejection fraction (LVEF) below 50%.
- Stable symptoms corresponding to New York Heart Association functional class I-II.
- Clinically stable and receiving stable, guideline-directed medical treatment at the maximum tolerated doses, as appropriate.
- Referred by the responsible cardiologist for cardiac rehabilitation according to usual clinical practice.
- No contraindication to supervised cardiac rehabilitation, cardiopulmonary exercise testing or the allocated exercise intervention.
- Written informed consent provided before enrolment.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Reina Sofia | Córdoba | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.