Chronic Heart Failure (CHF)CARECA-CHFNCT04790214
Effect of a Cardiac Rehabilitation Program on Chronic Heart Failure Patients in Yaoundé, Cameroon
A study testing CHF Patients in people with Chronic Heart Failure (CHF), run by Yaounde Central Hospital at 1 site in Cameroon.
Trial summary
CARECA-CHF study is a non-randomized, prospective, single-arm study, enrolled ambulatory patients with stable chronic heart failure [New York Heart Association (NYHA) class II/III]. Patients will be followed-up during a period of 06-08 weeks. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Chronic Heart Failure (CHF)
- What is being tested?
- CHF Patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCameroon
- Study dates
- 1 Mar 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable chronic heart failure confirmed by a cardiac ultrasound and whose severity is rated stage II or III of NYHA followed at Yaoundé central hospital and Yaoundé general hospital;
- Stable under treatment;
- Whose cardiac ultrasound is less than six months old;
- Having given his free and informed consent.
Who cannot join
- Poor adherence to the cardiac rehabilitation program activities;
- Patients lost insight the program;
- Withdrawal of informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
CARECA-CHF study is a non-randomized, prospective, single-arm study, enrolled ambulatory patients with stable chronic heart failure [New York Heart Association (NYHA) class II/III]. Patients will be followed-up during a period of 06-08 weeks. The aim of this study is to assess the effect of a cardiac rehabilitation program on patients with stable chronic heart failure in Yaoundé, Cameroon.
Read the detailed description
CARECA-CHF study is a non-randomized, prospective, single-arm study, multicentric study. Patients with stable chronic heart failure [New York Heart Association (NYHA) class II/III] will be enrolled ambulatory. The program will take place during a period of 06-08 weeks.
The aim of this study is to assess the effect of a cardiac rehabilitation program on patients with stable chronic heart failure in a resource-limited country.
- Conditions
- Chronic Heart Failure (CHF)
- Being tested
- CHF Patients
- Keywords
- Cardiac rehabilitation, Chronic Heart failure, Physical function, Cameroon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF PatientsOther
Cardiac rehabilitation program on CHF patients on 06-08 weeks. Program will include: physical aerobic re-training, therapeutic education on CHF, psychological follow-up, nutritional education
| Study group | Role | What they receive |
|---|---|---|
| Stable CHF patients | Experimental | Stable CHF patients on stage II/III based on the New York Heart Failure classification Receives: Other: CHF Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of VO2 max
Variation of VO2 max at baseline and the end of the study
Measured: 8 weeks
Secondary outcomes (10)
Variation in 6-minute walk test (6MWT) distance
Variation in 6MWT in meter distance from the baseline to week 6 or 8. By using pedometer
Measured: 8 weeks
Variation of duration of exercise and maximum load
variation in duration of exercise and maximum load expressed by watt power
Measured: 8 weeks
Variation in level of anxiety and depression;
Difference in level of anxiety and depression assessed by a questionnaire
Measured: 8 weeks
Change in quality of life assessed by the Minnesota Living With Heart Failure Questionnaire (MLWHFQ)
Change in quality of life assessed by the Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Minnesota Living With Heart Failure Questionnaire score at Week 8 adjusted for baseline
Measured: 8 weeks
Variation of time-domain heart rate variability (HRV) parameters
Variation of time-domain heart rate variability parameters before and after the intervention
Measured: 8 weeks
Variation of frequency-domain HRV parameters
variation of frequency-domain HRV parameters before and after the intervention. Variation of frequency-domain HRV parameters (HF, LF, LF/HF) before and after the intervention.
Measured: 8 weeks
Variation of index hypopnea-apnea index
Variation of variation of index hypopnea-apnea after 6-8 weeks of aerobic training.
Measured: 8 weeks
Variation of sleep quality index
variation of sleep quality index by Pittsburg questionnaire
Measured: 8 weeks
Variation of nocturnal saturation
Variation of nocturnal saturation by oxymeter
Measured: 8 weeks
Non adherence
evaluation of non adherence by questionnaire at the end of the study
Measured: 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart Failure (CHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with stable CHF in stage II or III of the New York Heart Association.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yaounde Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, CN NGANOU-GNINDJIO, MD, MSc, Yaounde Central Hospital
- Investigators
- Chris Nadège N Nganou-Gnindjio, MD, MAS, Principal investigator, Yaounde Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790214
- Sponsor's protocol ID
- CARECA-CHF
- Acronym
- CARECA-CHF
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Cardiac Rehabilitation Program on Chronic Heart Failure Patients in Yaoundé, Cameroon
- ClinicalTrials.gov ID
- NCT04790214
- Acronym / sponsor ID
- CARECA-CHF / CARECA-CHF
- Conditions
- Chronic Heart Failure (CHF)
- Keywords
- Cardiac rehabilitation, Chronic Heart failure, Physical function, Cameroon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yaounde Central HospitalOther government
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CARECA-CHF study is a non-randomized, prospective, single-arm study, enrolled ambulatory patients with stable chronic heart failure [New York Heart Association (NYHA) class II/III]. Patients will be followed-up during a period of 06-08 weeks. The aim of this study is to assess the effect of a cardiac rehabilitation program on patients with stable chronic heart failure in Yaoundé, Cameroon.
Detailed description
CARECA-CHF study is a non-randomized, prospective, single-arm study, multicentric study. Patients with stable chronic heart failure [New York Heart Association (NYHA) class II/III] will be enrolled ambulatory. The program will take place during a period of 06-08 weeks.
The aim of this study is to assess the effect of a cardiac rehabilitation program on patients with stable chronic heart failure in a resource-limited country.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with stable CHF in stage II or III of the New York Heart Association.
| Arm | Type | Receives |
|---|---|---|
| Stable CHF patients | Experimental | Other: CHF PatientsStable CHF patients on stage II/III based on the New York Heart Failure classification |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with stable chronic heart failure confirmed by a cardiac ultrasound and whose severity is rated stage II or III of NYHA followed at Yaoundé central hospital and Yaoundé general hospital;
- Stable under treatment;
- Whose cardiac ultrasound is less than six months old;
- Having given his free and informed consent.
Key exclusion criteria (3 listed)
- Poor adherence to the cardiac rehabilitation program activities;
- Patients lost insight the program;
- Withdrawal of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHF PatientsCardiac rehabilitation program on CHF patients on 06-08 weeks. Program will include: physical aerobic re-training, therapeutic education on CHF, psychological follow-up, nutritional education | Other | Stable CHF patients |
Primary outcome
Change of VO2 max
Time frame: 8 weeks
Variation of VO2 max at baseline and the end of the study
10 secondary outcomes
Variation in 6-minute walk test (6MWT) distance
Time frame: 8 weeks
Variation of duration of exercise and maximum load
Time frame: 8 weeks
Variation in level of anxiety and depression;
Time frame: 8 weeks
Change in quality of life assessed by the Minnesota Living With Heart Failure Questionnaire (MLWHFQ)
Time frame: 8 weeks
Variation of time-domain heart rate variability (HRV) parameters
Time frame: 8 weeks
Variation of frequency-domain HRV parameters
Time frame: 8 weeks
Variation of index hypopnea-apnea index
Time frame: 8 weeks
Variation of sleep quality index
Time frame: 8 weeks
Variation of nocturnal saturation
Time frame: 8 weeks
Non adherence
Time frame: 8weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Nadège N Nganou-Gnindjio, MD, MAS principal investigator
Yaounde Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHF Patients in people with Chronic Heart Failure (CHF), run by Yaounde Central Hospital at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of VO2 max (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.