Heart Failure With Preserved Ejection FractionPhase 4EMPA-PREDNCT06249945
EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease
A Phase 4 study testing Empagliflozin 25 MG in people with Heart Failure With Preserved Ejection Fraction and End Stage Renal Disease on Dialysis, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
The presence of CKD has been linked to the development of HFpEF. Currently, the treatment for HFpEF is limited. SGLT2i are one of the few drug classes that have proven efficacy in HFpEF in randomized controlled trials. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, End Stage Renal Disease on Dialysis
- What is being tested?
- Empagliflozin 25 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesTaiwan
- Study dates
- 5 Mar 2024to 31 Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥20 years old
- ESRD under chronic, maintenance dialysis with stable dry weight for the past 6 months
- Prior diagnosis of HFpEF, as defined by a score of ≥5 on the HFA-PEFF diagnostic algorithm.
Who cannot join
- Age <20 years old
- Ongoing pregnancy
- NYHA class IV heart failure
- Any hospitalization for heart failure within the past month Ongoing acute urinary tract infection at the time of screening
- Known acute genital infection
- Severe peripheral artery disease (Rutherford category 4-6)
Show all 11Show fewer
- Acute coronary syndrome, stroke or transient ischemic attack within the past month
- Recent initiation of chronic maintenance hemodialysis within 6 months
- Adjustment of dry weight with changes greater than 5% of body weight within the past month
- Documented left ventricular ejection fraction =<40% by any imaging modality within 1 month of screening
- Refused informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital Hsinchu Branch
Hsinchu, 300
Chih-Cheng Wu, PhD, 03 532 6151, chihchengwumd@gmail.com
Chih-Cheng Wu, PhD
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111
Donna SH Lin, MD, 0912902379, donna.lin24@gmail.com
Donna SH Lin, MD
About this study
Official title: The Safety and Efficacy of Empagliflozin in Patients With End-stage Renal Disease and Heart Failure With Preserved Ejection Fraction - a Randomized Controlled Trial
The presence of CKD has been linked to the development of HFpEF. Currently, the treatment for HFpEF is limited. SGLT2i are one of the few drug classes that have proven efficacy in HFpEF in randomized controlled trials. The results of mechanistic studies suggest that the benefits of SGLT2i on diastolic heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Despite the significance of HFpEF in patients with CKD, patients with advanced kidney disease have been excluded from studies investigating anti-heart failure drugs. The effects of SGLT2i in patients under maintenance dialysis are largely unknown. Past pharmacokinetics and pharmacodynamics studies on empagliflozin in patients with end-stage renal disease (ESRD) demonstrated that the use of empagliflozin in patients with ESRD seemed safe, yet its efficacy remains to be explored.
- Being tested
- Empagliflozin 25 MG, Placebo
- Keywords
- end-stage renal disease, sodium-glucose co-transporter 2 inhibitors, heart failure, diastolic function, empagliflozin
- Medical subject headings
- Kidney Failure, Chronic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 25 MGDrug
Also called Jardiance 25 MG
The medication will be packed in a customized sealed jar and labeled on the exterior of the jar.
PlaceboDrug
The placebo tablet is manufactured by Prince Pharmaceutical Co., Ltd, a leading manufacturer of nutritional supplements with certifications including cGMP, GMP, ISO, and HACCP. The Prince Pharmaceutical also provides Original Equipment Manufacturing (OEM)/Original Design Manufacturing (ODM) services for a wide array of tablet shapes, and post-processing techniques such as film coating and sugar coating.
| Study group | Role | What they receive |
|---|---|---|
| empagliflozin | Experimental | Jardiance, 25 mg, QD, for 6 months Receives: Drug: Empagliflozin 25 MG |
| Placebo | Placebo comparator | QD, for 6 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitral early (E) and late (A) diastolic filling velocity ratio (E/A)
As assessed by echocardiography, performed on non-dialysis day
Measured: 24 weeks of treatment
Secondary outcomes (26)
LV end-systolic volume index
As assessed by echocardiography, performed on non-dialysis day
Measured: 12 weeks and 24 weeks of treatment
LV end-diastolic volume index
As assessed by echocardiography, performed on non-dialysis day
Measured: 12 weeks and 24 weeks of treatment
LA volume index
As assessed by echocardiography, performed on non-dialysis day
Measured: 12 weeks and 24 weeks of treatment
LV ejection fraction
As assessed by echocardiography, performed on non-dialysis day
Measured: 12 weeks and 24 weeks of treatment
Left ventricular mass index
As assessed by echocardiography, performed on non-dialysis day
Measured: 12 weeks and 24 weeks of treatment
Global longitudinal strain
As assessed by echocardiography, performed on non-dialysis day
Measured: 12 weeks and 24 weeks of treatment
LA strain
As assessed by echocardiography, performed on non-dialysis day
Measured: 12 weeks and 24 weeks of treatment
Mitral inflow deceleration time
As assessed by echocardiography, performed on non-dialysis day
Measured: 12 weeks and 24 weeks of treatment
Mitral inflow deceleration time LV relative wall thickness
As assessed by echocardiography, performed on non-dialysis day
Measured: 12 weeks and 24 weeks of treatment
Tricuspid regurgitation peak gradient (TRPG)
As assessed by echocardiography, performed on non-dialysis day
Measured: 12 weeks and 24 weeks of treatment
NT-proBNP
Blood tests obtained pre-dialysis session
Measured: 4 weeks, 12 weeks and 24 weeks of treatment
HbA1c
Blood tests obtained pre-dialysis session
Measured: 4 weeks, 12 weeks and 24 weeks of treatment
Lipid profile
Blood tests obtained pre-dialysis session
Measured: 4 weeks, 12 weeks and 24 weeks of treatment
KCCQ-OS
Performed on non-dialysis day
Measured: 12 weeks and 24 weeks of treatment
6-minute walking distance
Performed on non-dialysis day
Measured: 12 weeks and 24 weeks of treatment
3-minute heart rate variability
During hemodialysis session
Measured: 12 weeks and 24 weeks of treatment
Blood pressure
Obtained pre-dialysis session
Measured: 12 weeks and 24 weeks of treatment
Major adverse cardiovascular events (composite of CV death, myocardial infarction, stroke)
By medical record confirmation and by interview
Measured: 24 weeks of treatment
Lower extremity non-traumatic amputation or revascularization
By medical record confirmation and by interview
Measured: 24 weeks of treatment
All-cause mortality
By medical record confirmation and by interview
Measured: 24 weeks of treatment
Hospitalization for heart failure
By medical record confirmation and by interview
Measured: 24 weeks of treatment
Hypoglycemic events
By medical record confirmation and by interview
Measured: 24 weeks of treatment
Diabetic ketoacidosis
By medical record confirmation and by interview
Measured: 24 weeks of treatment
Urinary tract infection
By medical record confirmation and by interview
Measured: 24 weeks of treatment
Genital tract infection
By medical record confirmation and by interview
Measured: 24 weeks of treatment
Hypokalemia
Blood tests obtained pre-dialysis session
Measured: 4 weeks, 12 weeks and 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start5 Mar 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Donna SH Lin, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial HospitalChih-Cheng Wu, MD. PhD, Principal investigator, National Taiwan University Hsin-Chu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249945
- Sponsor's protocol ID
- 202301126MINC
- Acronym
- EMPA-PRED
- Status last verified
- Nov 2024
- First submitted
- 21 Jan 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13.
PubMed 32061315Kalantar-Zadeh K, Jafar TH, Nitsch D, Neuen BL, Perkovic V. Chronic kidney disease. Lancet. 2021 Aug 28;398(10302):786-802. doi: 10.1016/S0140-6736(21)00519-5. Epub 2021 Jun 24.
PubMed 34175022Ronco C, Haapio M, House AA, Anavekar N, Bellomo R. Cardiorenal syndrome. J Am Coll Cardiol. 2008 Nov 4;52(19):1527-39. doi: 10.1016/j.jacc.2008.07.051.
PubMed 19007588Bansal N, Zelnick L, Bhat Z, Dobre M, He J, Lash J, Jaar B, Mehta R, Raj D, Rincon-Choles H, Saunders M, Schrauben S, Weir M, Wright J, Go AS; CRIC Study Investigators. Burden and Outcomes of Heart Failure Hospitalizations in Adults With Chronic Kidney Disease. J Am Coll Cardiol. 2019 Jun 4;73(21):2691-2700. doi: 10.1016/j.jacc.2019.02.071.
PubMed 31146814Kotecha D, Gill SK, Flather MD, Holmes J, Packer M, Rosano G, Bohm M, McMurray JJV, Wikstrand J, Anker SD, van Veldhuisen DJ, Manzano L, von Lueder TG, Rigby AS, Andersson B, Kjekshus J, Wedel H, Ruschitzka F, Cleland JGF, Damman K, Redon J, Coats AJS; Beta-Blockers in Heart Failure Collaborative Group. Impact of Renal Impairment on Beta-Blocker Efficacy in Patients With Heart Failure. J Am Coll Cardiol. 2019 Dec 10;74(23):2893-2904. doi: 10.1016/j.jacc.2019.09.059.
PubMed 31806133Ferro CJ, Mark PB, Kanbay M, Sarafidis P, Heine GH, Rossignol P, Massy ZA, Mallamaci F, Valdivielso JM, Malyszko J, Verhaar MC, Ekart R, Vanholder R, London G, Ortiz A, Zoccali C. Lipid management in patients with chronic kidney disease. Nat Rev Nephrol. 2018 Dec;14(12):727-749. doi: 10.1038/s41581-018-0072-9.
PubMed 30361677Shah KS, Fang JC. Is Heart Failure with Preserved Ejection Fraction a Kidney Disorder? Curr Hypertens Rep. 2019 Oct 10;21(11):86. doi: 10.1007/s11906-019-0993-0.
PubMed 31599363Ter Maaten JM, Damman K, Verhaar MC, Paulus WJ, Duncker DJ, Cheng C, van Heerebeek L, Hillege HL, Lam CS, Navis G, Voors AA. Connecting heart failure with preserved ejection fraction and renal dysfunction: the role of endothelial dysfunction and inflammation. Eur J Heart Fail. 2016 Jun;18(6):588-98. doi: 10.1002/ejhf.497. Epub 2016 Feb 10.
PubMed 26861140Cohen JB, Schrauben SJ, Zhao L, Basso MD, Cvijic ME, Li Z, Yarde M, Wang Z, Bhattacharya PT, Chirinos DA, Prenner S, Zamani P, Seiffert DA, Car BD, Gordon DA, Margulies K, Cappola T, Chirinos JA. Clinical Phenogroups in Heart Failure With Preserved Ejection Fraction: Detailed Phenotypes, Prognosis, and Response to Spironolactone. JACC Heart Fail. 2020 Mar;8(3):172-184. doi: 10.1016/j.jchf.2019.09.009. Epub 2020 Jan 8.
PubMed 31926856Anker SD, Butler J, Filippatos G, Ferreira JP, Bocchi E, Bohm M, Brunner-La Rocca HP, Choi DJ, Chopra V, Chuquiure-Valenzuela E, Giannetti N, Gomez-Mesa JE, Janssens S, Januzzi JL, Gonzalez-Juanatey JR, Merkely B, Nicholls SJ, Perrone SV, Pina IL, Ponikowski P, Senni M, Sim D, Spinar J, Squire I, Taddei S, Tsutsui H, Verma S, Vinereanu D, Zhang J, Carson P, Lam CSP, Marx N, Zeller C, Sattar N, Jamal W, Schnaidt S, Schnee JM, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Preserved Trial Investigators. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. 2021 Oct 14;385(16):1451-1461. doi: 10.1056/NEJMoa2107038. Epub 2021 Aug 27.
PubMed 34449189Verma S, Mazer CD, Yan AT, Mason T, Garg V, Teoh H, Zuo F, Quan A, Farkouh ME, Fitchett DH, Goodman SG, Goldenberg RM, Al-Omran M, Gilbert RE, Bhatt DL, Leiter LA, Juni P, Zinman B, Connelly KA. Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease: The EMPA-HEART CardioLink-6 Randomized Clinical Trial. Circulation. 2019 Nov 19;140(21):1693-1702. doi: 10.1161/CIRCULATIONAHA.119.042375. Epub 2019 Aug 22.
PubMed 31434508Ersboll M, Jurgens M, Hasbak P, Kjaer A, Wolsk E, Zerahn B, Brandt-Jacobsen NH, Gaede P, Rossing P, Faber J, Inzucchi SE, Gustafsson F, Schou M, Kistorp C. Effect of empagliflozin on myocardial structure and function in patients with type 2 diabetes at high cardiovascular risk: the SIMPLE randomized clinical trial. Int J Cardiovasc Imaging. 2022 Mar;38(3):579-587. doi: 10.1007/s10554-021-02443-5. Epub 2021 Oct 20.
PubMed 34669059Soga F, Tanaka H, Tatsumi K, Mochizuki Y, Sano H, Toki H, Matsumoto K, Shite J, Takaoka H, Doi T, Hirata KI. Impact of Dapagliflozin on the Left Ventricular Diastolic Function in Diabetic Patients with Heart Failure Complicating Cardiovascular Risk Factors. Intern Med. 2021;60(15):2367-2374. doi: 10.2169/internalmedicine.6127-20. Epub 2021 Aug 1.
PubMed 34334588Li X, Lu Q, Qiu Y, do Carmo JM, Wang Z, da Silva AA, Mouton A, Omoto ACM, Hall ME, Li J, Hall JE. Direct Cardiac Actions of the Sodium Glucose Co-Transporter 2 Inhibitor Empagliflozin Improve Myocardial Oxidative Phosphorylation and Attenuate Pressure-Overload Heart Failure. J Am Heart Assoc. 2021 Mar 16;10(6):e018298. doi: 10.1161/JAHA.120.018298. Epub 2021 Mar 13.
PubMed 33719499Pabel S, Wagner S, Bollenberg H, Bengel P, Kovacs A, Schach C, Tirilomis P, Mustroph J, Renner A, Gummert J, Fischer T, Van Linthout S, Tschope C, Streckfuss-Bomeke K, Hasenfuss G, Maier LS, Hamdani N, Sossalla S. Empagliflozin directly improves diastolic function in human heart failure. Eur J Heart Fail. 2018 Dec;20(12):1690-1700. doi: 10.1002/ejhf.1328. Epub 2018 Oct 17.
PubMed 30328645
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Empagliflozin in Patients With End-stage Renal Disease and Heart Failure With Preserved Ejection Fraction - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06249945
- Acronym / sponsor ID
- EMPA-PRED / 202301126MINC
- Keywords
- end-stage renal disease, sodium-glucose co-transporter 2 inhibitors, heart failure, diastolic function, empagliflozin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Feb 2024 (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 presence of CKD has been linked to the development of HFpEF. Currently, the treatment for HFpEF is limited. SGLT2i are one of the few drug classes that have proven efficacy in HFpEF in randomized controlled trials. The results of mechanistic studies suggest that the benefits of SGLT2i on diastolic heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Despite the significance of HFpEF in patients with CKD, patients with advanced kidney disease have been excluded from studies investigating anti-heart failure drugs. The effects of SGLT2i in patients under maintenance dialysis are largely unknown. Past pharmacokinetics and pharmacodynamics studies on empagliflozin in patients with end-stage renal disease (ESRD) demonstrated that the use of empagliflozin in patients with ESRD seemed safe, yet its efficacy remains to be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| empagliflozin | Experimental | Drug: Empagliflozin 25 MGJardiance, 25 mg, QD, for 6 months |
| Placebo | Placebo comparator | Drug: PlaceboQD, for 6 months |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥20 years old
- ESRD under chronic, maintenance dialysis with stable dry weight for the past 6 months
- Prior diagnosis of HFpEF, as defined by a score of ≥5 on the HFA-PEFF diagnostic algorithm.
Key exclusion criteria (11 listed)
- Age <20 years old
- Ongoing pregnancy
- NYHA class IV heart failure
- Any hospitalization for heart failure within the past month Ongoing acute urinary tract infection at the time of screening
- Known acute genital infection
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 |
|---|---|---|
| Empagliflozin 25 MGAlso: Jardiance 25 MGThe medication will be packed in a customized sealed jar and labeled on the exterior of the jar. | Drug | empagliflozin |
| PlaceboThe placebo tablet is manufactured by Prince Pharmaceutical Co., Ltd, a leading manufacturer of nutritional supplements with certifications including cGMP, GMP, ISO, and HACCP. The Prince Pharmaceutical also provides Original Equipment Manufacturing (OEM)/Original Design Manufacturing (ODM) services for a wide array of tablet shapes, and post-processing techniques such as film coating and sugar coating. | Drug | Placebo |
Primary outcome
Mitral early (E) and late (A) diastolic filling velocity ratio (E/A)
Time frame: 24 weeks of treatment
As assessed by echocardiography, performed on non-dialysis day
26 secondary outcomes
LV end-systolic volume index
Time frame: 12 weeks and 24 weeks of treatment
LV end-diastolic volume index
Time frame: 12 weeks and 24 weeks of treatment
LA volume index
Time frame: 12 weeks and 24 weeks of treatment
LV ejection fraction
Time frame: 12 weeks and 24 weeks of treatment
Left ventricular mass index
Time frame: 12 weeks and 24 weeks of treatment
Global longitudinal strain
Time frame: 12 weeks and 24 weeks of treatment
LA strain
Time frame: 12 weeks and 24 weeks of treatment
Mitral inflow deceleration time
Time frame: 12 weeks and 24 weeks of treatment
Mitral inflow deceleration time LV relative wall thickness
Time frame: 12 weeks and 24 weeks of treatment
Tricuspid regurgitation peak gradient (TRPG)
Time frame: 12 weeks and 24 weeks of treatment
NT-proBNP
Time frame: 4 weeks, 12 weeks and 24 weeks of treatment
HbA1c
Time frame: 4 weeks, 12 weeks and 24 weeks of treatment
Lipid profile
Time frame: 4 weeks, 12 weeks and 24 weeks of treatment
KCCQ-OS
Time frame: 12 weeks and 24 weeks of treatment
6-minute walking distance
Time frame: 12 weeks and 24 weeks of treatment
3-minute heart rate variability
Time frame: 12 weeks and 24 weeks of treatment
Blood pressure
Time frame: 12 weeks and 24 weeks of treatment
Major adverse cardiovascular events (composite of CV death, myocardial infarction, stroke)
Time frame: 24 weeks of treatment
Lower extremity non-traumatic amputation or revascularization
Time frame: 24 weeks of treatment
All-cause mortality
Time frame: 24 weeks of treatment
Hospitalization for heart failure
Time frame: 24 weeks of treatment
Hypoglycemic events
Time frame: 24 weeks of treatment
Diabetic ketoacidosis
Time frame: 24 weeks of treatment
Urinary tract infection
Time frame: 24 weeks of treatment
Genital tract infection
Time frame: 24 weeks of treatment
Hypokalemia
Time frame: 4 weeks, 12 weeks and 24 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 32061315GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13.
- Background: PubMed 34175022Kalantar-Zadeh K, Jafar TH, Nitsch D, Neuen BL, Perkovic V. Chronic kidney disease. Lancet. 2021 Aug 28;398(10302):786-802. doi: 10.1016/S0140-6736(21)00519-5. Epub 2021 Jun 24.
- Background: PubMed 19007588Ronco C, Haapio M, House AA, Anavekar N, Bellomo R. Cardiorenal syndrome. J Am Coll Cardiol. 2008 Nov 4;52(19):1527-39. doi: 10.1016/j.jacc.2008.07.051.
- Background: PubMed 31146814Bansal N, Zelnick L, Bhat Z, Dobre M, He J, Lash J, Jaar B, Mehta R, Raj D, Rincon-Choles H, Saunders M, Schrauben S, Weir M, Wright J, Go AS; CRIC Study Investigators. Burden and Outcomes of Heart Failure Hospitalizations in Adults With Chronic Kidney Disease. J Am Coll Cardiol. 2019 Jun 4;73(21):2691-2700. doi: 10.1016/j.jacc.2019.02.071.
- Background: PubMed 31806133Kotecha D, Gill SK, Flather MD, Holmes J, Packer M, Rosano G, Bohm M, McMurray JJV, Wikstrand J, Anker SD, van Veldhuisen DJ, Manzano L, von Lueder TG, Rigby AS, Andersson B, Kjekshus J, Wedel H, Ruschitzka F, Cleland JGF, Damman K, Redon J, Coats AJS; Beta-Blockers in Heart Failure Collaborative Group. Impact of Renal Impairment on Beta-Blocker Efficacy in Patients With Heart Failure. J Am Coll Cardiol. 2019 Dec 10;74(23):2893-2904. doi: 10.1016/j.jacc.2019.09.059.
- Background: PubMed 30361677Ferro CJ, Mark PB, Kanbay M, Sarafidis P, Heine GH, Rossignol P, Massy ZA, Mallamaci F, Valdivielso JM, Malyszko J, Verhaar MC, Ekart R, Vanholder R, London G, Ortiz A, Zoccali C. Lipid management in patients with chronic kidney disease. Nat Rev Nephrol. 2018 Dec;14(12):727-749. doi: 10.1038/s41581-018-0072-9.
- Background: PubMed 31599363Shah KS, Fang JC. Is Heart Failure with Preserved Ejection Fraction a Kidney Disorder? Curr Hypertens Rep. 2019 Oct 10;21(11):86. doi: 10.1007/s11906-019-0993-0.
- Background: PubMed 26861140Ter Maaten JM, Damman K, Verhaar MC, Paulus WJ, Duncker DJ, Cheng C, van Heerebeek L, Hillege HL, Lam CS, Navis G, Voors AA. Connecting heart failure with preserved ejection fraction and renal dysfunction: the role of endothelial dysfunction and inflammation. Eur J Heart Fail. 2016 Jun;18(6):588-98. doi: 10.1002/ejhf.497. Epub 2016 Feb 10.
- Background: PubMed 31926856Cohen JB, Schrauben SJ, Zhao L, Basso MD, Cvijic ME, Li Z, Yarde M, Wang Z, Bhattacharya PT, Chirinos DA, Prenner S, Zamani P, Seiffert DA, Car BD, Gordon DA, Margulies K, Cappola T, Chirinos JA. Clinical Phenogroups in Heart Failure With Preserved Ejection Fraction: Detailed Phenotypes, Prognosis, and Response to Spironolactone. JACC Heart Fail. 2020 Mar;8(3):172-184. doi: 10.1016/j.jchf.2019.09.009. Epub 2020 Jan 8.
- Background: PubMed 34449189Anker SD, Butler J, Filippatos G, Ferreira JP, Bocchi E, Bohm M, Brunner-La Rocca HP, Choi DJ, Chopra V, Chuquiure-Valenzuela E, Giannetti N, Gomez-Mesa JE, Janssens S, Januzzi JL, Gonzalez-Juanatey JR, Merkely B, Nicholls SJ, Perrone SV, Pina IL, Ponikowski P, Senni M, Sim D, Spinar J, Squire I, Taddei S, Tsutsui H, Verma S, Vinereanu D, Zhang J, Carson P, Lam CSP, Marx N, Zeller C, Sattar N, Jamal W, Schnaidt S, Schnee JM, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Preserved Trial Investigators. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. 2021 Oct 14;385(16):1451-1461. doi: 10.1056/NEJMoa2107038. Epub 2021 Aug 27.
- Background: PubMed 31434508Verma S, Mazer CD, Yan AT, Mason T, Garg V, Teoh H, Zuo F, Quan A, Farkouh ME, Fitchett DH, Goodman SG, Goldenberg RM, Al-Omran M, Gilbert RE, Bhatt DL, Leiter LA, Juni P, Zinman B, Connelly KA. Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease: The EMPA-HEART CardioLink-6 Randomized Clinical Trial. Circulation. 2019 Nov 19;140(21):1693-1702. doi: 10.1161/CIRCULATIONAHA.119.042375. Epub 2019 Aug 22.
- Background: PubMed 34669059Ersboll M, Jurgens M, Hasbak P, Kjaer A, Wolsk E, Zerahn B, Brandt-Jacobsen NH, Gaede P, Rossing P, Faber J, Inzucchi SE, Gustafsson F, Schou M, Kistorp C. Effect of empagliflozin on myocardial structure and function in patients with type 2 diabetes at high cardiovascular risk: the SIMPLE randomized clinical trial. Int J Cardiovasc Imaging. 2022 Mar;38(3):579-587. doi: 10.1007/s10554-021-02443-5. Epub 2021 Oct 20.
- Individual participant dataSharing planned: No
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Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
Recruiting
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
Heart Failure With Preserved Ejection Fraction
Recruiting
ELEVATE-HFpEF Clinical Study
Heart Failure With Preserved Ejection Fraction (HFpEF)
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.
Donna SH Lin, MD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
Chih-Cheng Wu, MD. PhD principal investigator
National Taiwan University Hsin-Chu Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin 25 MG in people with Heart Failure With Preserved Ejection Fraction and End Stage Renal Disease on Dialysis, run by National Taiwan University Hospital at 2 sites 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donna SH Lin, MD (+886912902379, Donna.lin24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitral early (E) and late (A) diastolic filling velocity ratio (E/A) (time frame: 24 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06249945, which also lists 22 linked publications.
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 16 Dec 2024.