Dapagliflozin in Mangement of Pulmonary Hypertension Patients

NCT06612086 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: Dapagliflozin in PH
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of SGLT2 (Dapagliflozin)on prognosis of patient with pulmonary Hypertension and Effect on RV function By speckle tract echocardiography at Assiut University Hospital.

Conditions

Pulmonary Hypertension

Keywords

Dapagliflozin; pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• Effect of Dapagliflozin on Right ventricle systolic function in patient with pulmonary Hypertension by speckle tract Echocardiography(RV Strain )

  patients with pulmonary hypertension , conventional parameters of RV systolic function, including TAPSE, FAC, s', and RVEF, may be normal despite abnormal RV strain, which is an additional reason for the usage of RV strain in these patients. RV longitudinal strain can identify subclinical RV dysfunction at the early phase of disease and may serve as an important marker of subtle RV systolic dysfunction when conventional parameters, primarily TAPSE, are in the normal range (25, 26).so investigator use RV strain to compare between RV function before and after taking of dapagliflozin

  6 month

Secondary Outcomes (1)

• Effect of Dapagliflozin on Quality of life for patient with pulmonary hypertension by Kansas City Cardiomyopathy Questionnaire Score

  6 month

Study Arms (1)

we follow up patient who take Dapagliflozin in patient with pulmonary hypertension

EXPERIMENTAL

we follow up patient who take Dapagliflozin in patient with pulmonary hypertension

Drug: Dapagliflozin (Forxiga)

Interventions

Dapagliflozin (Forxiga) DRUG

we study effect of dapagliflozin on patient with pulmonary hypertension by follow up RV function and prognosis of life of patient

we follow up patient who take Dapagliflozin in patient with pulmonary hypertension

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• that the patients were diagnosed with pulmonary hypertension By Right heart cath OR suspected By Echocardiograghy according to the ESC guidelines for pulmonary hypertension that they were aged 18 years or older

You may not qualify if:

• symptomatic hypotension (systolic blood pressure \< 95 mmHg)
• impaired renal function (eGFR \< 30 mL/min/1.73 m2 calculated according to the CKD-EPI formula) and serum potassium level \> 5.2 mmol/L
• hepatic dysfunction (defined as liver parameters such as ALT, AST, and/or ALP, which are three times above the upper 99-th percentile of the reference range
• biliary cirrhosis and cholestasis, active malignancies (regardless of the stage and type of malignancy)),
• the current use of hormone replacement therapy, chemotherapy, or immunotherapy
• Type 1 diabetes mellitus
• Acute pulmonary embolism (15)
• Signficant Primary valvular Heart disease
• Ischemic heart disease

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (7)

• Reddy YNV, Carter RE, Sorimachi H, Omar M, Popovic D, Alogna A, Jensen MD, Borlaug BA. Dapagliflozin and Right Ventricular-Pulmonary Vascular Interaction in Heart Failure With Preserved Ejection Fraction: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):843-851. doi: 10.1001/jamacardio.2024.1914.

  PMID: 39046727 BACKGROUND

• Li H, Zhang Y, Wang S, Yue Y, Liu Q, Huang S, Peng H, Zhang Y, Zeng W, Wu Z. Dapagliflozin has No Protective Effect on Experimental Pulmonary Arterial Hypertension and Pulmonary Trunk Banding Rat Models. Front Pharmacol. 2021 Nov 1;12:756226. doi: 10.3389/fphar.2021.756226. eCollection 2021.

  PMID: 34790128 BACKGROUND

• Kohler S, Zeller C, Iliev H, Kaspers S. Safety and Tolerability of Empagliflozin in Patients with Type 2 Diabetes: Pooled Analysis of Phase I-III Clinical Trials. Adv Ther. 2017 Jul;34(7):1707-1726. doi: 10.1007/s12325-017-0573-0. Epub 2017 Jun 19.

  PMID: 28631216 BACKGROUND

• Wang A, Yang K, Wang T, Zhang N, Tang H, Feng X. Effects of sodium-glucose cotransporter 2 inhibitors on risk of venous thromboembolism in patients with type 2 diabetes: A systematic review and meta-analysis. Diabetes Metab Res Rev. 2020 Jan;36(1):e3174. doi: 10.1002/dmrr.3174. Epub 2019 May 27.

  PMID: 31050384 BACKGROUND

• Mustapic I, Bakovic D, Susilovic Grabovac Z, Borovac JA. Impact of SGLT2 Inhibitor Therapy on Right Ventricular Function in Patients with Heart Failure and Reduced Ejection Fraction. J Clin Med. 2022 Dec 21;12(1):42. doi: 10.3390/jcm12010042.

  PMID: 36614843 BACKGROUND

• Solomon SD, McMurray JJV, Claggett B, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Jhund PS, Belohlavek J, Chiang CE, Borleffs CJW, Comin-Colet J, Dobreanu D, Drozdz J, Fang JC, Alcocer-Gamba MA, Al Habeeb W, Han Y, Cabrera Honorio JW, Janssens SP, Katova T, Kitakaze M, Merkely B, O'Meara E, Saraiva JFK, Tereshchenko SN, Thierer J, Vaduganathan M, Vardeny O, Verma S, Pham VN, Wilderang U, Zaozerska N, Bachus E, Lindholm D, Petersson M, Langkilde AM; DELIVER Trial Committees and Investigators. Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2022 Sep 22;387(12):1089-1098. doi: 10.1056/NEJMoa2206286. Epub 2022 Aug 27.

  PMID: 36027570 BACKGROUND

• Anker 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.

  PMID: 34449189 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident physician of cardiology

Model Details: Effect of SGLT2 (Dapagliflozin)on prognosis of patient with pulmonary Hypertension and Effect on RV function By speckle tract echocardiography at Assiut University Hospital.

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 25, 2024
• Study Start: October 25, 2024
• Primary Completion: September 10, 2025
• Study Completion (Estimated): October 10, 2026
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

EG (1)