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New treatment option for Heart Failure
Official title Sacubitril-valsartan in Patients With Heart Failure With Reduced Ejection Fraction From Rural Tanzania
ClinicalTrials.gov ID: NCT06704633
What this study is testing
What is Sacubitril / Valsartan Oral Tablet?
Sacubitril / Valsartan Oral Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Angiotensin-neprilysin inhibitors (ARNI) are beneficial in patients with heart failure with reduced ejection fraction. No study evaluating ARNI has been conducted in sub-Saharan Africa (except South Africa) yet, where heart failure is a major health problem.
- Phase 4: studies an already-approved treatment
- Time commitment: about 30 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Symptomatic heart failure NYHA class II-IV and
- Left ventricular ejection fraction (LVEF) ≤40% and
- Treatment with an ACE Inhibitor or an ARB, beta-blocker, and spironolactone in recommended dosages for at least 3 months, and
- Adherence to this therapy of at least 80%.
You likely can't join if
- Pregnancy
- Systolic blood pressure of less than 95 mmHg,
- eGFR below 30 ml per minute per 1.73 m2 of body-surface area
- Serum potassium level of more than 5.4 mmol per liter
- History of angioedema
- Unacceptable side effects prior during receipt of ACE inhibitors or ARBs
See the full eligibility criteria
- Symptomatic heart failure NYHA class II-IV and
- Left ventricular ejection fraction (LVEF) ≤40% and
- Treatment with an ACE Inhibitor or an ARB, beta-blocker, and spironolactone in recommended dosages for at least 3 months, and
- Adherence to this therapy of at least 80%.
- Pregnancy
- Systolic blood pressure of less than 95 mmHg,
- eGFR below 30 ml per minute per 1.73 m2 of body-surface area
- Serum potassium level of more than 5.4 mmol per liter
- History of angioedema
- Unacceptable side effects prior during receipt of ACE inhibitors or ARBs
- Inability to sign an informed consent form.
The study team makes the final eligibility decision.
Where it's taking place
- Ifakara, Morogoro, Tanzania
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 30 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ifakara, Morogoro, Tanzania. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.