BridgeMD
Dapagliflozin in patients with Right Heart Failure (Dapa-RHF)
EU CTIS ID: 2024-515044-23-01
What this study is testing
To demonstrate that dapagliflozin on top of standard of care is superior in reducing the primary outcome in patients with chronic right heart failure compared to standard of care plus placebo.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The Patient is willing and able to participate and provide written informed consent
- Age ≥ 18 years and < 90 years
- Presence of RHF defined as (criteria a-c must all be fulfilled): a) Reduced right ventricular systolic function or RV strain defined as at least one of the following tricuspid annular plane systolic excursion (TAPSE) <16 mm RV fractional area change (FAC) <35% Systolic pulmonary artery pressure (PAP sys) ≥35 mmHg combined with an extended inferior vena cava (>2,1 cm) with reduced collapsibility (<50%) during sniff inspiration assessed in echocardiography b) N-terminal pro-BNP (NT-proBNP) >125 pg/ml c) Clinical signs of right cardiac congestion (edema, and / or extended inferior vena cava (>2,1 cm) with reduced collapsibility (<50%) during sniff inspiration assessed in echocardiography and / or pleural effusion on sonography and / or chest radiograph) or need for diuretic therapy to prevent signs of congestion
- For women of childbearing potential* (until 1 year after menopause): a) Negative pregnancy test AND b) Use of highly effective methods of contraception during treatment plus 5 days after the end of study drug administration
You likely can't join if
- Heart failure with reduced left ventricular (LV) ejection fraction (LVEF <40%)
- Known contraindication for the treatment with dapagfliflozin
- Type 1 diabetes mellitus
- Incapacity to understand the nature, significance and implications of the clinical trial and / or to provide written informed consent
- Known active alcohol and / or drug abuse
- Current participation in another interventional trial
See the full eligibility criteria
Who can join
- The Patient is willing and able to participate and provide written informed consent
- Age ≥ 18 years and < 90 years
- Presence of RHF defined as (criteria a-c must all be fulfilled): a) Reduced right ventricular systolic function or RV strain defined as at least one of the following tricuspid annular plane systolic excursion (TAPSE) <16 mm RV fractional area change (FAC) <35% Systolic pulmonary artery pressure (PAP sys) ≥35 mmHg combined with an extended inferior vena cava (>2,1 cm) with reduced collapsibility (<50%) during sniff inspiration assessed in echocardiography b) N-terminal pro-BNP (NT-proBNP) >125 pg/ml c) Clinical signs of right cardiac congestion (edema, and / or extended inferior vena cava (>2,1 cm) with reduced collapsibility (<50%) during sniff inspiration assessed in echocardiography and / or pleural effusion on sonography and / or chest radiograph) or need for diuretic therapy to prevent signs of congestion
- For women of childbearing potential* (until 1 year after menopause): a) Negative pregnancy test AND b) Use of highly effective methods of contraception during treatment plus 5 days after the end of study drug administration
What rules you out
- Heart failure with reduced left ventricular (LV) ejection fraction (LVEF <40%)
- Known contraindication for the treatment with dapagfliflozin
- Type 1 diabetes mellitus
- Incapacity to understand the nature, significance and implications of the clinical trial and / or to provide written informed consent
- Known active alcohol and / or drug abuse
- Current participation in another interventional trial
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca personnel and/or personnel at the study site)
- Pregnancy or lactating women
- Body mass index >50 kg/m2
- Known acute or chronic liver disease with clinical signs of severe impairment of liver function (e.g., ascites, oesophageal varices, coagulopathy)
- Hepatic impairment defined as aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment)
- Pulmonary arterial hypertension (PAH, PH Group I)
- Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after randomization
- Active symptomatic infection (e. g. with body temperature ≥38°C) requiring anti-infective treatment (based on investigator's clinical judgement)
- Acute (within 30 days) pulmonary embolism
- Acute (within 30 days) right ventricular myocardial infarction
- Current medication with any SGLT2 inhibitor
- Chronic kidney disease (CKD) or acute kidney injury with eGFR < 25 ml/min/1,73 m², or end-stage renal failure with the need for chronic dialysis treatment
- Systolic blood pressure (SBP) <90 mmHg at screening visit confirmed on 2 consecutive measurements
- Any contraindication for cardiac magnetic resonance imaging (MRI)
- Known intolerance or hypersensitivity to dapagliflozin
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.