HypotensionPhase 4NCT04575675
Dapagliflozin on Hypotensive Heart Failure Patients After Sacubitril/Valsartan Therapy
A Phase 4 study testing Dapagliflozin, Sacubitril-Valsartan and Beta blocker in people with Hypotension and Heart Failure, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
Trial summary
The DAPA-HF trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure events and cardiovascular death comparing to placebo in patients with reduced ejection fraction further to standard of care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypotension, Heart Failure
- What is being tested?
- Dapagliflozin, Sacubitril-Valsartan and Beta blocker
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 May 2020to 30 Dec 2020
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- chronic symptomatic HF with New York Heart Association (NYHA) class II-IV and left ventricular ejection fraction (LVEF) less than 40%
- treatment with stable and maximal tolerable dose of Sac/Val, beta-blocker with or without mineralocorticoid receptor antagonist
- 6-minute walking-distance (6MWD)≥ 100meters and ≤425 meters at enrollment
- systolic blood pressure ≤100 mmHg at enrollment
Who cannot join
- hemodialysis
- severe co-morbidities with life expectancy less than 1 year
- type 1 diabetes mellitus
- ever treated with any type of sodium glucose cotransporter 2 inhibitor (SGLT2i)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dapagliflozin on Hypotensive Patients With Depressed Left Ventricular Ejection Fraction After Sacubitril/Valsartan Therapy
The DAPA-HF trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure events and cardiovascular death comparing to placebo in patients with reduced ejection fraction further to standard of care. However, hypotensive patients who generally have higher risks comparing to normotensive patients, were under represented in the DAPA-HF. The investigators aimed to evaluate clinical effects of dapagliflozin on hypotensive heart failure patients receiving chronic sacubitril/valsartan treatment.
Read the detailed description
The DAPA-HF trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure (HF) events and cardiovascular death comparing to placebo in patients with reduced ejection fraction further to standard of care. However, hypotensive patients who generally have higher risks comparing to normotensive patients, were under represented in the DAPA-HF. The investigators aimed to evaluate clinical effects of dapagliflozin on hypotensive HFrEF patients receiving chronic sacubitril/valsartan (Sal/Val) treatment.
This is an investigator-initiated, interventional, prospective. open-label study. The inclusion criteria were (1) chronic symptomatic HF with New York Heart Association (NYHA) class II-IV and LVEF less than 40%, (2) treatment with stable and maximal tolerable dose of Sac/Val, beta-blocker with or without mineralocorticoid receptor antagonist (MRA), (3) 6-minute walking-distance (6MWD)≥ 100meters and ≤425 meters at enrollment, (4) systolic blood pressure ≤100 mmHg at enrollment. The exclusion criteria were (1) type 1 diabetes mellitus, (2) patients previously treated with any sodium glucose co-transporter 2 inhibitor (SGLT2i).
After applying the inclusion and exclusion criteria, if the participants had type 2 diabetes mellitus, the participants will receive dapagliflozin 10mg daily directly. If the participants did not have history of diabetes mellitus, the participants will be allocated to either receiving dapagliflozin 10mg daily or receiving standard heart failure treatment without dapagliflozin.
Vital signs and laboratory tests were examined at baseline, 2-week, 4-week and 12-week. Six-minute-walking-test, five-level EuroQol five dimensions (EQ-5D-5L) questionnaire and visual analogue scale (VAS) were collected at baseline and at 12-week.
- Conditions
- Hypotension, Heart Failure
- Being tested
- Dapagliflozin, Sacubitril-Valsartan, Beta blocker, Mineralocorticoid Receptor Antagonist, Cardiac resynchronization therapy and/or implantable cardioverter defibrillator
- Keywords
- Heart failure, Dapagliflozin, Sacubitril/valsartan
- Medical subject headings
- Hypotension, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Forxiga
Dapagliflozin 10mg once daily
Sacubitril-ValsartanDrug
Also called Entresto
Sacubitril-Valsartan, maximal tolerated dosage
Beta blockerDrug
Also called Concor, Betaloc zok, Nebilet, Carvedilol
Cardio-selective beta-blocker, including carvedilol, bisoprolol, metoprolol or nebivolol
Mineralocorticoid Receptor AntagonistDrug
Also called Aldactin, Inspra
Mineralocorticoid receptor antagonist, including spironolactone or eplerenone
Cardiac resynchronization therapy and/or implantable cardioverter defibrillatorDevice
CRT-P, CRT-D or ICD if clinically indicated
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin with standard-of-care therapies for heart failure, including sacubitril/valsartan, beta-blocker, MRA, ICD and CRT Receives: Drug: Dapagliflozin; Drug: Sacubitril-Valsartan; Drug: Beta blocker; Drug: Mineralocorticoid Receptor Antagonist; Device: Cardiac resynchronization therapy and/or implantable cardioverter defibrillator |
| Standard of care | Placebo comparator | Standard-of-care therapies for heart failure, including sacubitril/valsartan, beta-blocker, MRA, ICD and CRT Receives: Drug: Sacubitril-Valsartan; Drug: Beta blocker; Drug: Mineralocorticoid Receptor Antagonist; Device: Cardiac resynchronization therapy and/or implantable cardioverter defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walking distance
Measuring walking distance within 6 minutes
Measured: 12 weeks
Secondary outcomes (2)
EQ-5D-5L
Measuring health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.This version of EQ-5D has five-level scale, The number of levels of severity was classified into: having no problems, having slight problems, having moderate problems, having severe problems and being unable to do/having extreme problems. This version can define 3,125 (5x5x5x5x5) different health states.
Valuation of the EQ-5D-5L was then calcuated by the Taiwanese hybrid model, range from -1.0259 to 1. [PLoS One 13(12):e0209344]. Higher score indicates better health status.
Measured: 12 weeks
EQ-Visual analogue scale (EQ-VAS)
Evaluating the participants' overall health status. The participant would be asked to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start29 May 2020
- Primary completion25 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheng-Hsin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hung-Yu Chang, Cheng-Hsin General Hospital
- Investigators
- Hung-Yu Chang, MD, Principal investigator, Cheng-Hsin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575675
- Sponsor's protocol ID
- ChenghsinGH
- Status last verified
- Jul 2021
- First submitted
- 26 Aug 2020
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dapagliflozin on Hypotensive Patients With Depressed Left Ventricular Ejection Fraction After Sacubitril/Valsartan Therapy
- ClinicalTrials.gov ID
- NCT04575675
- Acronym / sponsor ID
- ChenghsinGH
- Conditions
- Hypotension, Heart Failure
- Keywords
- Heart failure, Dapagliflozin, Sacubitril/valsartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Cheng-Hsin General HospitalUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 5 Oct 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.
The DAPA-HF trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure events and cardiovascular death comparing to placebo in patients with reduced ejection fraction further to standard of care. However, hypotensive patients who generally have higher risks comparing to normotensive patients, were under represented in the DAPA-HF. The investigators aimed to evaluate clinical effects of dapagliflozin on hypotensive heart failure patients receiving chronic sacubitril/valsartan treatment.
Detailed description
The DAPA-HF trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure (HF) events and cardiovascular death comparing to placebo in patients with reduced ejection fraction further to standard of care. However, hypotensive patients who generally have higher risks comparing to normotensive patients, were under represented in the DAPA-HF. The investigators aimed to evaluate clinical effects of dapagliflozin on hypotensive HFrEF patients receiving chronic sacubitril/valsartan (Sal/Val) treatment.
This is an investigator-initiated, interventional, prospective. open-label study. The inclusion criteria were (1) chronic symptomatic HF with New York Heart Association (NYHA) class II-IV and LVEF less than 40%, (2) treatment with stable and maximal tolerable dose of Sac/Val, beta-blocker with or without mineralocorticoid receptor antagonist (MRA), (3) 6-minute walking-distance (6MWD)≥ 100meters and ≤425 meters at enrollment, (4) systolic blood pressure ≤100 mmHg at enrollment. The exclusion criteria were (1) type 1 diabetes mellitus, (2) patients previously treated with any sodium glucose co-transporter 2 inhibitor (SGLT2i).
After applying the inclusion and exclusion criteria, if the participants had type 2 diabetes mellitus, the participants will receive dapagliflozin 10mg daily directly. If the participants did not have history of diabetes mellitus, the participants will be allocated to either receiving dapagliflozin 10mg daily or receiving standard heart failure treatment without dapagliflozin.
Vital signs and laboratory tests were examined at baseline, 2-week, 4-week and 12-week. Six-minute-walking-test, five-level EuroQol five dimensions (EQ-5D-5L) questionnaire and visual analogue scale (VAS) were collected at baseline and at 12-week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin, Drug: Sacubitril-Valsartan, Drug: Beta blocker, Drug: Mineralocorticoid Receptor Antagonist, Device: Cardiac resynchronization therapy and/or implantable cardioverter defibrillatorDapagliflozin with standard-of-care therapies for heart failure, including sacubitril/valsartan, beta-blocker, MRA, ICD and CRT |
| Standard of care | Placebo comparator | Drug: Sacubitril-Valsartan, Drug: Beta blocker, Drug: Mineralocorticoid Receptor Antagonist, Device: Cardiac resynchronization therapy and/or implantable cardioverter defibrillatorStandard-of-care therapies for heart failure, including sacubitril/valsartan, beta-blocker, MRA, ICD and CRT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- chronic symptomatic HF with New York Heart Association (NYHA) class II-IV and left ventricular ejection fraction (LVEF) less than 40%
- treatment with stable and maximal tolerable dose of Sac/Val, beta-blocker with or without mineralocorticoid receptor antagonist
- 6-minute walking-distance (6MWD)≥ 100meters and ≤425 meters at enrollment
- systolic blood pressure ≤100 mmHg at enrollment
Key exclusion criteria (4 listed)
- hemodialysis
- severe co-morbidities with life expectancy less than 1 year
- type 1 diabetes mellitus
- ever treated with any type of sodium glucose cotransporter 2 inhibitor (SGLT2i)
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 |
|---|---|---|
| DapagliflozinAlso: ForxigaDapagliflozin 10mg once daily | Drug | Dapagliflozin |
| Sacubitril-ValsartanAlso: EntrestoSacubitril-Valsartan, maximal tolerated dosage | Drug | Dapagliflozin, Standard of care |
| Beta blockerAlso: Concor, Betaloc zok, Nebilet, CarvedilolCardio-selective beta-blocker, including carvedilol, bisoprolol, metoprolol or nebivolol | Drug | Dapagliflozin, Standard of care |
| Mineralocorticoid Receptor AntagonistAlso: Aldactin, InspraMineralocorticoid receptor antagonist, including spironolactone or eplerenone | Drug | Dapagliflozin, Standard of care |
| Cardiac resynchronization therapy and/or implantable cardioverter defibrillatorCRT-P, CRT-D or ICD if clinically indicated | Device | Dapagliflozin, Standard of care |
Primary outcome
6-minute walking distance
Time frame: 12 weeks
Measuring walking distance within 6 minutes
2 secondary outcomes
EQ-5D-5L
Time frame: 12 weeks
EQ-Visual analogue scale (EQ-VAS)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Hung-Yu Chang, MD principal investigator
Cheng-Hsin General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin, Sacubitril-Valsartan and Beta blocker in people with Hypotension and Heart Failure, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
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 4 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: finished, as of the sponsor's last update on 2 Aug 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
6-minute walking distance (time frame: 12 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 2 Aug 2021.