Heart Failure, DiastolicPhase 2STADIA-HFpEFNCT04475042
Stratified Treatment to Ameliorate Diastolic Left Ventricular Stiffness in Heart Failure With Preserved Ejection Fraction
A Phase 2 study testing Dapagliflozin in people with Heart Failure, Diastolic, run by Mariëlle Scheffer at 1 site in Netherlands.
Trial summary
A 35-week, single-center, prospective, double-blind, controlled, randomized, 2x2 crossover, interventional Phase II study, investigating the effect of treatment with dapagliflozin 10mg od on Left Ventricular distensibility in patients with early HFpEF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diastolic
- What is being tested?
- Dapagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2020to May 2022
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at time of screening
- Symptomatic chronic heart failure patients with diagnosis of heart failure and:
- NYHA class II-IV
- Preserved systolic Left Ventricular (LV) function, defined by: LV Ejection Fraction (LVEF) ≥ 50% and LV end-diastolic volume index <97 ml/m2
- Evidence of diastolic LV dysfunction and at least 1 out of the 5 following additional criteria:
- H2FPEF score ≥ 6;
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- HFA-PEFF score ≥ 5;
- Pulmonary capillary wedge pressure > 15 mmHg at rest or > 25 mmHg with exercise assessed with right heart catheterization;
- Cardiac MRI T1 derived extracellular volume <29% at screening
- Oral diuretics, if prescribed to the patient according to local guidelines and at the discretion of the investigator, should be stable for at least 1 week prior to baseline visit
- Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial
Who cannot join
- Reduced systolic LV function (LVEF < 50%), measured at any time point in the history of the patient
- Obstructive coronary artery disease with evidence of ischemia
- Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA in past 90 days prior to screening visit
- More than mild valve stenosis
- More than moderate aortic and/or mitral valve regurgitation
- Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. hemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (stress cardiomyopathy), hypertrophic (obstructive) cardiomyopathy or known pericardial constriction
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- History of mitral valve repair or replacement
- Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm at screening
- Acute decompensation that requires intravenous loop diuretics
- Systolic blood pressure ≥ 180 mmHg. If SBP > 150 mmHg and < 180 mmHg, the patient should be receiving at least 3 antihypertensive drugs at screening or baseline visit
- Symptomatic hypotension and/or a SBP < 100 mmHg at screening or baseline visit
- Impaired renal function, defined as eGFR < 30 ml/min/1.73 m2
- Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3x upper limit of normal or history of cirrhosis with evidence of portal hypertension
- Hemoglobin < 9 g/dl at screening
- Chronic obstructive pulmonary disease, more than GOLD class 2
- Pulmonary function test with FEV1/FVC < 80%
- Primary pulmonary arterial hypertension
- Type 1 Diabetes Mellitus
- History of ketoacidosis
- Any documented active or suspected malignancy or history of malignancy within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix or low risk prostate cancer (biopsy Gleason score of ≤ 6 and clinical stage T1c or T2a)
- Current use or prior use of a SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor within 3 months prior to screening visit. Discontinuation of a SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor for the purposes of study enrolment is not permitted
- Pregnancy or lactation
- Any (clinical) condition that, in the investigator's opinion, would jeopardize patients safety while participating in this trial, or may prevent the patient from adhering to the trial protocol
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
OLVG
Amsterdam, North Holland, 1091
Marielle Scheffer, 0031205994889, mailcardio.research@olvg.nl
About this study
Official title: Stratified Treatment to Ameliorate Diastolic Left Ventricular Stiffness in Heart Failure With Preserved Ejection Fraction. A 35-week, Single-center, Prospective, Double-blind, Controlled, Randomized, 2x2 Crossover, Interventional Phase II Study, Investigating the Effect of Treatment With Dapagliflozin 10mg od on Left Ventricular Distensibility in Patients With Early HFpEF.
A 35-week, single-center, prospective, double-blind, controlled, randomized, 2x2 crossover, interventional Phase II study, investigating the effect of treatment with dapagliflozin 10mg od on Left Ventricular distensibility in patients with early HFpEF.
- Conditions
- Heart Failure, Diastolic
- Being tested
- Dapagliflozin, Placebo
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
10mg od
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Dapagliflozin - washout period - placebo Receives: Drug: Dapagliflozin; Drug: Placebo |
| Group B | Active comparator | Placebo - washout period - Dapagliflozin Receives: Drug: Dapagliflozin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular (LV) e'
echocardiographically measured
Measured: 13 weeks
E/e'/LV end-diastolic volume index
echocardiographically measured
Measured: 13 weeks
Secondary outcomes (5)
Kansas City Cardiomyopathy Questionnaire
Measured: 13 weeks
6-minute walk test
Measured: 13 weeks
Left atrial volume
Echocardiographically derived volume
Measured: 13 weeks
Diastolic parameters
Echocardiographically derived function, filling and compliance of Left Ventricular
Measured: 13 weeks
Left atrial function
Echocardiographically derived strain analysis, resevoir, conduit and booster pump function
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Jul 2020
- Primary completionNov 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, DiastolicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mariëlle Scheffer
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Mariëlle Scheffer, Onze Lieve Vrouwe Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475042
- Sponsor's protocol ID
- 19.185
- Acronym
- STADIA-HFpEF
- Status last verified
- Sep 2020
- First submitted
- 8 Jul 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratified Treatment to Ameliorate Diastolic Left Ventricular Stiffness in Heart Failure With Preserved Ejection Fraction. A 35-week, Single-center, Prospective, Double-blind, Controlled, Randomized, 2x2 Crossover, Interventional Phase II Study, Investigating the Effect of Treatment With Dapagliflozin 10mg od on Left Ventricular Distensibility in Patients With Early HFpEF.
- ClinicalTrials.gov ID
- NCT04475042
- Acronym / sponsor ID
- STADIA-HFpEF / 19.185
- Conditions
- Heart Failure, Diastolic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Mariëlle SchefferUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 17 Jul 2020 (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.
A 35-week, single-center, prospective, double-blind, controlled, randomized, 2x2 crossover, interventional Phase II study, investigating the effect of treatment with dapagliflozin 10mg od on Left Ventricular distensibility in patients with early HFpEF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Dapagliflozin, Drug: PlaceboDapagliflozin - washout period - placebo |
| Group B | Active comparator | Drug: Dapagliflozin, Drug: PlaceboPlacebo - washout period - Dapagliflozin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years at time of screening
- Symptomatic chronic heart failure patients with diagnosis of heart failure and:
- Cardiac MRI T1 derived extracellular volume <29% at screening
- Oral diuretics, if prescribed to the patient according to local guidelines and at the discretion of the investigator, should be stable for at least 1 week prior to baseline visit
- Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial
Key exclusion criteria (23 listed)
- Reduced systolic LV function (LVEF < 50%), measured at any time point in the history of the patient
- Obstructive coronary artery disease with evidence of ischemia
- Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA in past 90 days prior to screening visit
- More than mild valve stenosis
- More than moderate aortic and/or mitral valve regurgitation
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 |
|---|---|---|
| Dapagliflozin10mg od | Drug | Group A, Group B |
| PlaceboPlacebo | Drug | Group A, Group B |
Primary outcome
Left Ventricular (LV) e'
Time frame: 13 weeks
echocardiographically measured
E/e'/LV end-diastolic volume index
Time frame: 13 weeks
echocardiographically measured
5 secondary outcomes
Kansas City Cardiomyopathy Questionnaire
Time frame: 13 weeks
6-minute walk test
Time frame: 13 weeks
Left atrial volume
Time frame: 13 weeks
Diastolic parameters
Time frame: 13 weeks
Left atrial function
Time frame: 13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin in people with Heart Failure, Diastolic, run by Mariëlle Scheffer at 1 site in Netherlands.
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 11 inclusion and 23 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 22 Sep 2020. 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 Netherlands. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Marielle Scheffer, MD (0031205994889, mailcardio.research@olvg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular (LV) e' (time frame: 13 weeks). The study lists 2 primary outcomes in all. 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 22 Sep 2020.